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Last update 13 Feb 2025
Olverembatinib
Last update 13 Feb 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Orebatinib, Oribatinib, 奥瑞巴替尼 + [14] |
Target |
Mechanism Bcr-Abl T315I inhibitors(BCR-ABL T315I mutation inhibitors), c-Kit inhibitors(Stem cell growth factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date |
RegulationFast Track (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN) |
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Structure/Sequence
Molecular FormulaC31H35F3N6O7S2 |
InChIKeyLEVIGHXVOVROGW-UHFFFAOYSA-N |
CAS Registry1421783-64-3 |
Related
44
Clinical Trials associated with OlverembatinibNCT06817720
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
NCT06757855
A Multicenter, Single-arm I/II Clinical Study of Olverembatinib Combined With Venetoclax and Azacitidine in in Blast Phase Ph Chromosome- Chronic Myeloid Leukemia
ChiCTR2400094086
A clinical study of olverembatinib in combination with APG-1252 for the treatment of relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia or T-cell acute lymphoblastic lymphoma
100 Clinical Results associated with Olverembatinib
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100 Translational Medicine associated with Olverembatinib
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100 Patents (Medical) associated with Olverembatinib
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84
Literatures (Medical) associated with Olverembatinib01 Feb 2025CANCER
Patient‐reported outcomes in Chinese patients with chronic myeloid leukemia receiving olverembatinib: Quality of life matters!
Author: Eşkazan, Ahmet Emre
Because patients with chronic myeloid leukemia in chronic phase live longer in the era of tyrosine kinase inhibitors, evaluating health‐related quality of life, especially by patient‐reported outcome measures, plays an important role in the management of their disease. Although more comparative data are still needed, this study demonstrated that olverembatinib therapy improved health‐related quality of life significantly over time in heavily treated patients with chronic myeloid leukemia.
01 Jan 2025CANCER
Patient‐reported outcomes in adults with tyrosine kinase inhibitor‐resistant chronic myeloid leukemia receiving olverembatinib therapy
Article
Author: Li, Weiming ; Xu, Na ; Song, Yongping ; Men, Lichuang ; Du, Xin ; Zhang, Yanli ; Liu, Xiaoli ; Meng, Li ; Hu, Yu ; Chen, Suning ; Liu, Bingcheng ; Jiang, Qian ; Zhu, Huanling ; Yu, Lu
Abstract:
Background:
The objective of this study was to assess patient‐reported outcomes (PROs), including health‐related quality of life (HRQoL) and anxiety and depression symptoms, and to identify associated variables in patients with tyrosine kinase inhibitor (TKI)‐resistant chronic myeloid leukemia (CML) in chronic‐phase (CP) or accelerated‐phase (AP) who were receiving olverembatinib.
Methods:
Patients in multicenter studies were invited to complete the European Organization for Research and Treatment of Cancer Quality‐of‐Life Core 30 Questionnaire, the Self‐Rating Anxiety Scale, and the Self‐Rating Depression Scale at baseline and regularly during olverembatinib therapy. The time trends in PROs were estimated with a linear model using a generalized estimating equation based on an independent working correlation matrix. A generalized estimating equation model was used to assess the variables associated with PROs.
Results:
In total, 146 patients with CML‐CP or CML‐AP were included in this study. Scores on seven items from the European Organization for Research and Treatment of Cancer Quality‐of‐Life Core 30 Questionnaire, including global health, physical functioning, emotional functioning, fatigue, dyspnea, diarrhea, and financial difficulties, improved significantly over time during olverembatinib therapy. In multivariate analysis, age younger than 40 years was significantly associated with greater improvement in social functioning (p = .033), and CML‐CP (vs. CML‐AP) was associated with greater improvements in dyspnea (p = .031) and diarrhea (p = .031) over time. Scores on the Self‐Rating Anxiety Scale and the Self‐Rating Depression Scale decreased significantly over time during olverembatinib treatment (p < .001).
Conclusions:
The authors concluded that HRQoL significantly improved over time during olverembatinib therapy in heavily treated patients with TKI‐resistant CML, especially among those who were younger and those who had CML‐CP. Anxiety symptoms also significantly decreased over time.
01 Jan 2025Cancer Medicine
The Multi‐Kinase Inhibitor GZD824 (Olverembatinib) Shows Pre‐Clinical Efficacy in Endometrial Cancer
Article
Author: Liu, Dongli ; Ford, Caroline E. ; Glubb, Dylan ; O'Mara, Tracy
ABSTRACT:
Objective:
Endometrial cancer is one of the few cancers for which mortality is still increasing. A lack of treatment options remains a major challenge, particularly for some subtypes of the disease. GZD824, also known as olverembatinib, is a multi‐kinase inhibitor previously investigated in clinical trials for chronic myeloid leukaemia and Ph+ acute lymphoblastic leukaemia as a BCR‐ABL inhibitor. This study aimed to investigate the pre‐clinical efficacy of GZD824 for the treatment of EC.
Methods:
Here, we undertook pre‐clinical evaluation of GZD824 in seven endometrial cancer cell lines (HEC‐1‐A, HEC‐1‐B, MFE296, RL95‐2, Ishikawa, KLE and ARK‐1), one normal immortalised endometrium derived cell line (E6E7hTERT) and primary mesothelial and fibroblast cells isolated from normal omentum samples.
Results:
GZD824 inhibited the proliferation of all endometrial cancer cell lines, which were significantly more sensitive to GZD824 compared to normal cells (p = 0.030). GZD824 significantly inhibited migration in Ishikawa (endometrioid) and ARK1 (serous) endometrial cancer cell lines and significantly inhibited invasion in the ARK1 cells. Whole transcriptome regulation following two doses (0.1 and 1 μM) of GZD824 in Ishikawa and ARK1 cells was investigated via RNA‐seq, and key components of enriched pathways were investigated at the translational level. Key pathways altered included ROR1/Wnt, GCN2‐ATF4, epithelial to mesenchymal transition (EMT) and PI3K‐AKT.
Conclusion:
Together, these studies support further investigation of GZD824 as a potential therapeutic agent in endometrial cancer, potentially in combination with immune checkpoint inhibitors.
195
News (Medical) associated with Olverembatinib24 Jan 2025
Drug ApprovalPhase 3IPOLicense out/inAcquisition
24 Jan 2025
Phase 3IPODrug Approval
23 Jan 2025
Drug ApprovalIPOPhase 3AcquisitionBiosimilar
100 Deals associated with Olverembatinib
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Aggressive-Phase Chronic Myelocytic Leukemia | CN | 24 Nov 2021 | |
| Chronic phase chronic myeloid leukemia | CN | 24 Nov 2021 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| SDH-deficient Gastrointestinal Stromal Tumors | Phase 3 | CN | 11 Nov 2024 | |
| SDH-deficient Gastrointestinal Stromal Tumors | Phase 3 | CN | 11 Nov 2024 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | CN | 31 Aug 2023 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | CN | 31 Aug 2023 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | AU | 31 Aug 2023 | |
| Philadelphia chromosome-positive acute lymphoblastic leukemia in relapse | Phase 2 | CN | 12 Jul 2022 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 2 | CN | 08 Apr 2019 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 2 | CN | 08 Apr 2019 | |
| Philadelphia Chromosome Positive Acute Myeloid Leukemia | Phase 1 | US | 06 Aug 2024 | |
| Acute Lymphoblastic Leukemia | Phase 1 | CA | 22 Jul 2022 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 1 | T315I variants | 80 | bneuufqlij(gjotmvzkew) = all grades, 31 [39%]; grade 3 or higher, 10 [13%] tisymncucw (hyzwpgdqyq ) View more | Positive | 01 Jan 2025 | ||
NEWS Manual  | Not Applicable | Chronic phase chronic myeloid leukemia Second line | 43 | twrdxnrxoh(mibblesgao) = gjdrcbtjqs zbufomsxpu (ifvsbwanhk ) View more | Positive | 09 Dec 2024 | |
ASH2024 Manual | Phase 1 | 66 | Total | jokozxvnbd(rsgoglthzj) = ducjqaizze phjbaxahwk (vyxhecjqel ) View more | Positive | 08 Dec 2024 | |
(T315I mutation) | jokozxvnbd(rsgoglthzj) = vcovvscstt phjbaxahwk (vyxhecjqel ) View more | ||||||
ASH2024 Manual | Not Applicable | 26 | rooqljxpom(kpdschjeiu) = No patients had adverse reactions leading to dose reduction or discontinuation, and no treatment-related non-hematological adverse reactions were observed. hzpuzxjjkd (dydokwrqhu ) | Positive | 07 Dec 2024 | ||
NCT05521204 (ASH2024) Manual | Phase 2 | 10 | vmjcgtgzsc(ujmusfawml) = cntzquahmy hccalyqgyu (mvgkyfcdak ) View more | Positive | 07 Dec 2024 | ||
NCT04260022 (Literature) Manual | Phase 1 | 80 | filrvluzvl(skzeogoyjc) = wdhlxzidcb zvxmyealpq (exzdhfbmdc, 29.6 - 55.9) View more | Positive | 21 Nov 2024 | ||
(prior ponatinib treatment) | filrvluzvl(skzeogoyjc) = qjyxewkyte zvxmyealpq (exzdhfbmdc, 19.9 - 56.1) View more | ||||||
Phase 1 | SDH-deficient Gastrointestinal Stromal Tumors SDHD Deficient Expression | 26 | Olverembatinib 20 mg | fhluxnjwbz(xzvstzwers) = letnfyzwuc teskipkesx (njlgaafsmz, 12.9 - 38.6) | Positive | 13 Sep 2024 | |
Not Applicable | - | Olverembatinib 30 mg QOD | mzrjbcqlqv(zpcesosimx) = 38.8% experienced elevated blood creatine phosphokinase fxzakbvdxe (elikwyfmfx ) View more | - | 04 Sep 2024 | ||
PRNewswire Manual | Not Applicable | 159 | fmqrpeurmf(whzhojcnaq) = the top 3 severe symptom burdens at baseline were financial difficulties, fatigue, and insomnia. Eight scale items including global health, physical functioning, emotional functioning, fatigue, pain, dyspnea, diarrhea and financial difficulties improved significantly during olverembatinib therapy. No scale deteriorated significantly. In multivariate analysis, age < 40 years was associated with better improvement of social functioning (p = 0.021); CP (vs. AP), better improvement of dyspnea (p = 0.028) and diarrhea (p = 0.042); achieving MMR, better improvement of global health (p = 0.005), nausea and vomiting (p = 0.009), and diarrhea (p = 0.001). vhwsvbtqdn (zmrtzwyzjv ) View more | Positive | 18 Jun 2024 | ||
Phase 1 | 32 | rxxxadnanx(kciskyhjcp) = pediwklubc snvtxzlgiu (ffmprdshku ) View more | Positive | 24 May 2024 | |||
rxxxadnanx(kciskyhjcp) = ltvjfazbkb snvtxzlgiu (ffmprdshku ) View more |
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